The purpose of this FOA is to solicit applications for a
Coordinating Center (CC) to provide national leadership for the NIH-DoD-VA
Health Care Systems (HCS) Research Collaboratory program on
non-pharmacological approaches to pain management and comorbidities in U.S.
military personnel, veterans and their families. For brevity, this initiative
will be referred to as the “NIH-DoD-VA Pain Management Collaboratory.” Coordinating
Center applicants will need to: 1) develop, adapt, and adopt technical and
policy guidelines and best practices for the effective conduct of research in
partnership with health care systems focused on military personnel, veterans,
and their families; 2) work collaboratively with and provide technical,
design, and other support to Demonstration Project teams, to develop and
implement a pragmatic trial protocol; and 3) disseminate widely
Collaboratory-endorsed policies and best practices and lessons learned in the
Demonstration Projects for implementing research within health care settings.
The Coordinating Center will also serve as the central resource for the
activities of the NIH-DoD-VA Pain Management Collaboratory program, including
providing administrative support for a Steering Committee and its
subcommittees.

Key Dates

Posted Date

December 12, 2016

Open Date (Earliest Submission Date)

February 3, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

March 3, 2017, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2017

Advisory Council Review

August 2017

Earliest Start Date

November 15, 2017

Expiration Date

March 4, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

Since 2001, more than 2.5 million U.S. troops have been
deployed for Operation New Dawn, Operations Enduring Freedom (OEF) in
Afghanistan, and Iraqi Freedom (OIF) in Iraq. The all-volunteer military
experienced multiple redeployments to the war zone, extensive use of the
reserve components of the military and National Guard, that also involved the
deployment of women and parents of young children. Many of these deployed
service members sustained severe injuries that in previous wars would have
resulted in death. Significant and continuing improvements in outer tactical
vests (body armor) and helmets saved lives. However, despite these
improvements, many service members returning from these operations, and from
other military operations, experienced pain, traumatic brain injuries (TBIs),
symptoms of post-traumatic stress disorder (PTSD), suicidal thoughts or
behaviors, substance abuse, and/or related comorbidities. Studies report nearly
45% of soldiers and 50% of veterans experience pain on a regular basis and
there is significant overlap between chronic pain, PTSD, and persistent
post-concussive symptoms. There is an ongoing problem with pain among
military and veteran populations and an incomplete evidence base for effective
pain management. Opioid medications are often prescribed for the treatment of
chronic pain, but chronic use is associated with the potential for misuse,
abuse, and dependence and often fails to adequately control pain. As a result,
there is a need for non-pharmacological approaches to complement
pharmacological strategies for pain management and to reduce the needs and
hazards of excessive reliance on opioids.

The NIH, DoD, and VA have been working individually and
collaboratively to develop and improve pain management approaches for military
personnel, veterans and their families by adopting changes in clinical
protocols, and implementing research initiatives. Some of these efforts
include: 1) increasing availability of non-pharmacological approaches for pain
management in some VA and DoD medical facilities; 2) DoD funding of studies on
comparative effectiveness of integrative approaches for chronic pain and
co-morbid conditions; 3) VA funding of studies examining the efficacy of yoga
therapy for chronic pain, including low back pain, and for PTSD; 4) funding of
the Defense and Veterans Center for Integrative Pain Management; and 5) a 2014
NIH-VA joint funding initiative resulting in the support of 13 research
projects focused on the development and testing of non-pharmacological
approaches to pain management.

In a separate but related effort, the 2010 Patient
Protection and Affordable Care Act required the Department of Health and Human
Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a
public health problem. In June, 2011, the Institute of Medicine (IOM)
released a Consensus Report on "Relieving Pain in America: A Blueprint for
Transforming Prevention, Care, Education, and Research” (http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx).
The report notes that chronic pain affects an estimated 116 million American
adults—more than the total affected by heart disease, cancer, and diabetes
combined. Pain also costs the nation up to $635 billion each year in medical
treatment and lost productivity. The report notes that ideally, most patients
with severe persistent pain would obtain pain care from an interdisciplinary
team using an integrated approach that would target multiple dimensions of the
chronic pain experience including disease management, reduction in pain
severity, and improved functioning, emotional well-being and health-related
quality of life.

In the last two decades, health care delivery organizations
have played valuable roles in research projects and health surveillance
activities funded by NIH institutes and centers (ICs), other U.S. Department of
Health and Human Services agencies, the DoD, and the VA. The increased adoption
of health information technology tools contributes to the increased feasibility
for researchers, in partnership with health care delivery organizations, to
conduct studies in “real world” settings with large numbers of participants.

Although there is a recognized and compelling need for
research to identify effective complementary non-pharmacological approaches for
pain management and other comorbid conditions in military and veteran
populations, many challenges exist. Ethical and regulatory issues must be
addressed to perform research in health care delivery settings. Health care
providers focus on providing the best treatment, based on current knowledge,
whereas research typically focuses on studying which treatments work best in a
precisely defined population. Further, research studies have frequently used
endpoints that are not part of routine patient assessment or care, and may
propose interventions that are challenging to implement in many health care
delivery settings. Bridging the gap between research and practice is an
important step in the direction of providing increased benefits to the
patients. Education and engagement of providers and patients on the value of
research in health care settings are urgently needed. This NIH-DoD-VA Pain
Management Collaboratory will create a broad framework to address and overcome
these challenges.

Purpose

The overall goal of this initiative, jointly supported by
the NIH, DoD, and VA, is to develop the capacity to implement cost-effective
large-scale pragmatic clinical research in military and veteran health care
delivery organizations focusing on non-pharmacological approaches to pain
management and other comorbid conditions. Types of non-pharmacological
approaches to study could include, but are not limited to, mindfulness/meditative
(e.g., mindfulness based stress reduction, meditation), and movement (e.g.
structured exercise, tai chi, yoga) interventions, manual (e.g. spinal
manipulation, massage, acupuncture) therapies, neuromodulation (e.g., electrical
stimulation), and psychological and behavioral interventions (e.g., cognitive
behavioral therapy), or an integrative approach that involves more than one
intervention. Of special interest are integrated models of multi-modal care that
are delivered in different settings (e.g. pain care that could include
collaborative care, care management, care delivered through tele-care,
peer-coaches, or informal caregivers etc.)

The NIH-DoD-VA Pain Management Collaboratory Initiative,
will:

establish a Coordinating Center to provide leadership and
technical expertise in all aspects of research supporting the design and
execution of high impact demonstration projects that conduct pragmatic clinical
trials on non-pharmacological approaches for pain management and other comorbid
conditions in veteran or military health care systems (supported by this FOA).

support the design and execution of a set of high-impact
Demonstration Projects that will conduct pragmatic clinical trials on
non-pharmacological approaches to pain management and comorbidities with
patients in health care delivery systems that provide care to military
personnel, veterans and their families (supported through the companion FOA)

make data, tools, best practices, and resources from these and
other projects available to facilitate research partnerships with HCS.

Demonstration Projects, solicited under a separate companion
FOA (RFA-AT-17-001), will be selected based on the importance of the scientific
questions and the potential to address impediments to research on
non-pharmacological approaches to pain management and other comorbid conditions
in health care delivery organizations serving military personnel, veterans and
their families. Demonstration Projects will need to collaborate with the
coordinating center to develop, initiate and implement a research protocol,
which includes ethical and regulatory oversight. Demonstration projects will be
phased awards with an initial planning (UG3) phase followed by an
implementation (UH3) phase. During the UG3 phase the Demonstration
Project teams, in cooperation with the Coordinating Center, will determine
resource needs, pilot test data extraction methods for patient identification
and outcome assessment, and protection of human subjects. Those
demonstration projects meeting milestones during the UG3 planning phase will be
approved to move to the implementation phase (UH3).

Coordinating
Center Overview

The Coordinating Center is expected to provide leadership
for the NIH-DoD-VA Pain Management Collaboratory program. The
Coordinating Center will need to:

1) develop, adapt, and adopt technical and policy guidelines and best practices
for the effective conduct of pragmatic clinical trials in partnership with
health care systems focused on military personnel, veterans, and their
families;

2) work collaboratively with, and provide technical, design,
and other support to Demonstration Project teams, to develop and implement a
research protocol; and

3) widely disseminate NIH-DoD-VA Pain Management Collaboratory -endorsed
policies and best practices and lessons learned for implementing research within
health care settings that deliver health care to U.S. military personnel,
veterans, and their families.

The Coordinating Center will also serve as the central
resource for the activities of the NIH-DoD-VA Pain Management Collaboratory program,
including providing administrative support to a Steering Committee and its work
groups. The coordinating center will be responsible for facilitating
harmonization and sharing of tools and approaches within, and across
Demonstration Projects.

Program Governance will be accomplished using the NIH
cooperative agreement mechanism (see Section VI.2 Cooperative Agreement Terms
and Conditions of Award). Close interaction with the NIH, DoD and VA and
Demonstration Project awardees will be required under this program.

Work Groups will be established and managed by the
coordinating center as a core collaborative activity. The Work Groups will
provide a forum for discussion of challenges and solutions across projects;
harmonized and standardized policies and processes will be vetted in these
groups. Work Groups are expected to address, at a minimum, the following
areas: Stakeholder Engagement, Ethical/Regulatory, Study Design/Biostatistics,
Phenotype/Outcomes, Electronic Health Records (EHR), and Data Sharing. Work
Groups will be chaired by Coordinating Center staff and include individuals
from the Demonstration Projects, and staff from the NIH, DoD, and VA.

A Steering Committee will address issues that span all
projects, provide input into the policies and processes of the NIH-DoD-VA Pain
Management Collaboratory, provide guidance to the Coordinating Center and
demonstration projects, and assist in dissemination of policies and processes
that enable research in health care systems that serve U.S. military personnel,
veterans, and their families. At a minimum, the Steering Committee will be
chaired by the PD/PI of the Coordinating Center and have representation from
the following groups: one representative from each of the Demonstration
Projects; one representative from each Work Group; Program Coordinators from
the NIH, DoD, and VA, and other representatives as appropriate from various
NIH, DoD, and VA programs; and NIH/VA/DoD program officers/project scientists
for each award made as part of the initiative. All members are expected to
actively participate in all Steering Committee activities. NIH, DoD, and VA
representation may not exceed 40 percent of the committee membership.

It is also expected that the Coordinating Center will engage
with groups and organizations (e.g., NIH, DOD, VA, private organizations)
working in similar areas, and will stay abreast of extant and emerging
information and efforts (e.g., PROMIS, CTSAs, The Interagency Pain Research
Coordinating Committee), regulations, and technical advances that could
facilitate research on non-pharmacological approaches to pain management and
other comorbid conditions.

The Coordinating Center is expected to have at a minimum significant
knowledge in the following areas:

Provide national leadership and engage all stakeholders in
advancing policies and practices that enhance the broad participation of
researchers and health care systems in research focused on non-pharmacological
approaches to pain management and comorbidities in U.S. military personnel,
veterans and their families

Improve the capability, methods, and technologies used in
addressing research important to effect health improvement regarding
non-pharmacological pain management

Specific tasks and accomplishments of the Coordinating Center and
associated Working Groups

Approaches that allow the use of patient reported outcomes or
other descriptive protocols, and algorithms developed elsewhere to address
questions relevant to NIH-DoD-VA Pain Management Collaboratory

Basic requirements for technical, policy, and workflow practices,
needed for health systems participation in research

Defining the needs, requirements and approaches to conduct
pragmatic clinical trials on non-pharmacological approaches to pain management
and other comorbid conditions in partnership with eligible health care systems

Processes and agreements needed to address regulatory
requirements for single and multiple health care systems that provide services
to military personnel, veterans and their families

Processes and best practices for ethical conduct of pragmatic
clinical trials in eligible health care settings that obtain input from health
care system leadership, patients, family members, providers, researchers.

Mechanisms for leveraging novel collaboration and communication
strategies, as well as creativity and flexibility to innovate on an ongoing
basis

Coordinating
Center Director Effort

The NIH-DoD-VA Pain Management Collaboratory program
Coordinating Center Director will be the individual responsible for the overall
management of the Coordinating Center including coordination with each of the
Demonstration project teams. The relationship between the Coordinating
Center and the Demonstration Projects should be a partnership in the planning
phase.

Administrative
support for NIH-DoD-VA Pain Management Collaboratory Program

Administrative support for the activities of the NIH-DoD-VA
Pain Management Collaboratory program, should include, but not be limited to:

Developing a public website for communication and sharing of
activities, events, and resources of the program.

Providing a “private” collaboration space for the demonstration
projects and Coordinating Center.

Organizational and logistical support for facilitating the
activities of the Steering Committee and Work Groups (e.g., Stakeholder
Engagement, Ethical/Regulatory, Study Design/Biostatistics, Phenotype/Outcomes,
Electronic Health Records (EHR), and Data Sharing).

Developing and supporting standards and mechanisms for publicly sharing
data, resources, and code developed and utilized under this initiative in
compliance with privacy regulations.

Organizing and supporting the costs and logistics for two face to
face meetings in the first year, and an annual meeting in subsequent years of
the NIH-DoD-VA Pain Management Collaboratory Steering Committee in the greater
Washington, D.C. area.

Planning and hosting face to face, video or tele-conference
meetings of the Working Groups, Steering Committee, and any subcommittees on a
regular basis.

The NIH-DoD-VA Pain Management Collaboratory program
encourages sharing of data, resources policies, best practices, materials, and
tools to facilitate collaboration, use, and replication of results. In
addition, the NIH-DoD-VA Pain Management Collaboratory program encourages sharing
of data from Demonstration Projects; data sharing should be done in a timely
manner with appropriate privacy and confidentiality protections. Thus,
the NIH-DoD-VA Pain Management Collaboratory program expects grantees to
implement a Resources and Data Sharing Plan consistent with these program
goals.

While software development is not the primary goal of this
program, it is expected that software or sets of code may be developed under
this program by the Coordinating Center or the Demonstration projects. The
NIH-DoD-VA Pain Management Collaboratory program, therefore, encouragessharing
of software and code that is developed under this program. Grantees and
their sub-contractors are expected to implement software sharing plans
consistent with the goals of this program, if sharing of this information will
be useful to the scientific community to more efficiently conduct pragmatic
trials in the future. This may include, but is not limited to, software, tools,
or code sets for extraction of or for defining data in EHRs, clinical systems,
and other health care data systems; software developed for implementation of
new workflows for research studies; analytic and analysis programs; or tools
for incorporation of patient input. Sharing software under this program,
will broaden its availability to researchers, health care delivery
organizations, research institutions, and government health care systems. The
conditions for sharing should include terms that permit the dissemination and
commercialization of enhanced or customized versions of the software, or
incorporation into other packages. The software should be available to and
modifiable by individuals outside the applicant institution and its
collaborating organizations.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities. See
Section VI.2 for additional information about the substantial involvement for
this FOA.

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NIH ($1,650,000 from NCCIH, $ 250,000 from NIDA and
$100,000 from ORWH) intends to commit $2 million in FY 2017 to fund 1 award.

Award Budget

Direct costs requested for the first three years may not
exceed $1.3 million per year; direct costs for years 4 to 6 may not exceed
$1.0 million per year.

Award Project Period

The total project period for an application submitted in
response to this FOA may not exceed 6 years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

In terms of experience and expertise, in addition to a
strong experienced leader, the Coordinating Center PD/PI should have the
following qualities:

Technical expertise in accessing and extracting information from
electronic health records (EHRs) of the health care systems that deliver care
to all of the following groups: U.S. military, veterans, and their families and
relevant clinical systems for research purposes;

Knowledge of the regulatory requirements for conducting pragmatic
clinical trials within both military and veteran health systems including
knowledge of policies and procedures for the use of health care data for
research purposes and experience in conducting research that complies with
clinical practice and research regulations for these systems.

Experience with the ethical issues related to pragmatic clinical
trials, clinical care, quality improvement, population health, and
surveillance. Specifically, knowledge of the human subjects protection
requirements for military and veteran health care systems.

Experience working with a variety of stakeholders including
patients, research participants, practitioners, researchers, hospital and
research informatics and technical personnel, and senior managers of health
care and research organizations on workflows and practices of military and
veteran health care systems.

Knowledge of workflows and research team practices in design and
implementation of pragmatic clinical trials.

Knowledge of current data models, algorithms, and approaches used
by the various eligible networks and practices to define clinical phenotypes,
extract information, define endpoints, and discover errors in data.

Knowledge of privacy regulations related to both the military and
veteran health care systems

Project management experience in taking a research question from
idea, through implementation, to completion.

Ability to solve technical challenges effectively and respectfully
with all relevant communities.

Knowledge of patient reported outcomes and patient reported
assessments in health care EHRs of military and veteran health care systems,
research study management tools, including electronic transfer of information
from mobile and other devices.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed, with the following exceptions or additional
requirements:

For this specific FOA, the Research Strategy section is
limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

Biographical Sketches should reflect how the investigator
team, collaborators, and other personnel are well suited to the project. The
team should include expertise and experience in non-pharmacological approaches
to pain management and comorbidities in U.S. military personnel, veterans and
their families, including but not limited to, experience with data extraction
in meaningful ways from EHRs and other clinical systems, experience with
ethical issues related to research and care boundaries, experience in design,
conduct, and analysis of pragmatic clinical trials, and experience in
collaborative research with a variety of stakeholders.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

The Coordinating Center Director must be able to devote at
least 30% effort (3.6 person months) to this program.

The applicant must include funds for the Coordinating Center
PD/PI and key personnel to support and attend two one and half day NIH-DoD-VA
Pain Management Collaboratory program meetings in the first year and an annual one-and-half-day
meeting in subsequent years in the greater Washington D.C. area. Funds need to
be included for the coordinating center to host the meeting, including the
meeting room and all other expenses. Demonstration project staff will travel
their own people on their budgets.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: Coordinating center applicants must indicate their
willingness to cooperate with Demonstration Project teams, the NIH, DoD and VA
in the development and design of research approaches, methods, processes,
policies, and tools used in this program.

The Coordinating Center will have five to seven Work Groups
that will work with the Demonstration Projects to assist with optimizing the
design and implementation; gathering lessons learned across projects; and
developing guidance and best practice documents. The application must provide
details of the Work Groups including staffing, planned activities, and
deliverables. For example, the application must describe how Coordinating
Center Work Groups will review the study design and biostatistical assumptions
of the proposed Demonstration Projects; work with the Demonstration Project
teams to develop detailed plans for site implementation, determine resource
needs, test data extraction methods for patient identification and outcome
assessment; and review plans for all aspects of ethical and regulatory
oversight and protection of human subjects.

To meet the needs and responsibilities of the Coordinating
Center, applicants should describe their group expertise and prior experience
working collaboratively in research consortia and other collaborative projects
to accomplish shared goals for the team as a whole, without repeating
information on individual biosketches. Additionally, applications should
describe the team's experience conducting pragmatic trials in both military and
veteran health care settings such that they can provide technical expertise to
other investigators proposing to do pragmatic trials in these settings. A
description of the team's ongoing record of accomplishment in support of
coordination, collaboration, and communication of large national-level
inclusive networks or consortia should be provided.

The applicant should also describe the specific tasks and accomplishments
needed to meet the objectives of the NIH-DoD-VA Pain Management Collaboratory Coordinating
Center, which could include, but are not limited to:

Provide national leadership and engage all stakeholders in
advancing policies and practices that enhance the broad participation of
researchers and health care systems in research focused on non-pharmacological
approaches to pain management and comorbidities in U.S. military personnel,
veterans and their families

Improve the capability, methods, and technologies used in
addressing research important to effect health improvement regarding
non-pharmacological pain management

Specific tasks and accomplishments of the Coordinating Center and
associated Working Groups

Approaches that allow the use of patient reported outcomes or
other descriptive protocols, and algorithms developed elsewhere to address
questions relevant to NIH-DoD-VA Pain Management Collaboratory

Basic requirements for technical, policy, and workflow practices,
needed for health systems participation in research

Defining the needs, requirements and approaches to conduct
pragmatic clinical trials on non-pharmacological approaches to pain management
and other comorbid conditions in partnership with eligible health care systems

Processes and agreements needed to address regulatory requirements
for single and multiple health care systems that provide services to military
personnel, veterans and their families

Processes and best practices for ethical conduct of pragmatic
clinical trials in eligible health care settings that obtain input from health
care system leadership, patients, family members, providers, researchers.

Mechanisms for leveraging novel collaboration and communication
strategies, as well as creativity and flexibility to innovate on an ongoing
basis

Coordinating
Center Transition Plan

Although it is unknown whether the Coordinating Center will
be renewed, the applicant should provide an administrative support plan
describing how it would facilitate the transition of activities to a potential
successor at the end of the period. This should include describing the
transition of any software, hardware, and licenses, as well as standard
operating procedures, best practices, content of the public website and
collaboration site and other documentation for management of the coordinating
center period. Applicants should describe processes through which these
resources will be made available to the community after the NIH-DoD-VA Pain
Management Collaboratory period of support ends.

Resource
Sharing Plan: Individuals are expected to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan. Applicants are
expected to provide a description of the resources that will be made broadly
available including policies, practices, materials, and tools to facilitate
collaboration, reuse, and replication of the project. Applications should provide
descriptions of how privacy and confidentiality will be maintained. The plan
must include a description of how data will be shared to allow for transparency
and reproducibility of study findings (e.g. access to data, data enclave, or
data repository). The Data Sharing Plan should describe how information will be
shared in a timely manner with appropriate privacy and confidentiality
protections to facilitate further research, reuse of data, and replication.

Software Sharing Plan

A Software Sharing Plan, with appropriate timelines, is
expected to be included in the application. Applicants should describe what
software will be generated by the award and how they will determine which
software is potentially useful to the scientific community and how it will be
shared. There is no particular software dissemination license required for
this program. However, NIH does have goals for software sharing applicants
should keep in mind the following goals:

The software should be freely available to biomedical researchers,
health care delivery systems, research institutions, and government health care
systems and researchers.

The terms should also permit the dissemination and
commercialization of enhanced or customized versions of the software, or
incorporation of the software or components of it into other software packages.

The terms of software availability should include the ability of
individuals outside the applicant institution and its collaborating
organizations to modify the source code and to share modifications with other
colleagues.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by components
of participating organizations, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to
notify the NCCIH Referral Office by email at SchmidMa@mail.nih.gov when the
application has been submitted. Please include the FOA number and title, PD/PI
name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following: This
FOA includes Additional Review Considerations on Resource and Data Sharing and
Software Sharing which will be considered by reviewers but will not be scored
individually or influence the overall impact score.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an
important problem or a critical barrier to progress in the field? Is there a
strong scientific premise for the project? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Will the Coordinating Center
provide national leadership and engage all stakeholders in advancing policies
and practices that enhance the broad participation of researchers and health
care systems in research focused on non-pharmacological approaches to pain
management and comorbidities in U.S. military personnel, veterans and their
families? If the aims of the center are achieved, how will clinical
research, translation of research into practice, and participation by relevant
health care delivery organizations in research be improved? How will
successful completion of the aims change the capability, methods, and technologies
used in addressing research important to effect health improvement regarding
non-pharmacological pain management and comorbidities in U.S. military
personnel, veterans and their families?

Investigator(s)

Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they
demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD/PI, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Are the PD(s)/PI(s), collaborators,
and other personnel well suited to the project? Do the personnel have the
appropriate breadth of expertise and experience in non-pharmacological
approaches to pain management and comorbidities in U.S. military personnel,
veterans and their families, including but not limited to, experience with data
extraction in meaningful ways from EHRs and other clinical systems, experience
with ethical issues related to research and care boundaries, experience in
design, conduct, and analysis of pragmatic clinical trials, and experience in
collaborative research with a variety of stakeholders? Do the PD(s)/PI(s)
and collaborators have experience conducting pragmatic trials in both military
and veteran health care settings such that they can provide technical expertise
to other investigators proposing to do pragmatic trials in these settings? Have
they demonstrated an ongoing record of accomplishment in support of
coordination, collaboration, and communication of large national-level
inclusive networks or consortia? Are the investigators willing to
collaborate with the NIH, DoD, and VA, and Demonstration Project awardees to
meet the goals objectives of this program?

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Does the application include
mechanisms for leveraging novel collaboration and communication strategies?
Does the application indicate creativity and flexibility to innovate on an
ongoing basis?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators presented strategies to
ensure a robust and unbiased approach, as appropriate for the work proposed? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed? Have
the investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Will the proposed approach allow
for rapid deployment of Coordinating Center personnel and collaborative tools
to enable speedy Demonstration Project team planning and testing? Is the
plan for administrative support of the NIH-DoD-VA Pain Management Collaboratory
program facilitative of the proposed plan for support of the Demonstration
Projects and will it add to the productivity of the program?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate
the following additional items while determining scientific and technical
merit, and in providing an overall impact score, but will not give separate
scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

Not Applicable

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NCCIH, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Because the DoD, VA, and several NIH ICOs (NCCIH, NINDS, NIDA,
NIAAA, NICHD, NINR, ORWH) are participating in this FOA even though they are
not contributing funds and they are participating in the companion FOA, they
will be allowed to provide recommendations for reviewers and attend the review
of the applications for this FOA. Assignment to a Scientific Review Group will
be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the National Center for
Complementary and Integrative Health (NCCIH). Applications will compete for
available funds with all other recommended applications . Following initial
peer review, recommended applications will receive a second level of review by
the National Advisory Council for Complementary and Integrative Health. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Willingness of PD(s)/PI(s) to collaborate with the NIH, DoD, and
VA.

NCCIH will be the primary funder of this U24; For the companion
FOA, each participating IC/agency will fund or co-fund individual UG3/UH3s. The
applications, scores and summary statements will be shared with the DoD and VA
since they are participating in this FOA even though they are not contributing
funds

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique) via
the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award Conditions
and Information for NIH Grants website. This includes any recent
legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH
grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH, DoD, and the VA as
defined below.

The PD(s)/PI(s)
will have the primary responsibility for:

Determining approaches, designing, and setting project milestones
and implementing the project plan for the Coordinating Center

Cooperating in sharing knowledge and experience with various
tools and approaches utilized in conducting research in health care settings on
non-pharmacological approaches to pain management and comorbidities in military
personnel, veterans and their families, including their strengths and
weaknesses

Cooperating in sharing issues related to data quality, data
management, data biases and errors, query quality and sampling challenges, and
pitfalls in utilization of health care data for research

Collaborating with other awardees in harmonizing and sharing of
tools, methods, and approaches within and between Demonstrating Projects

Cooperating with others in sharing of study designs, methods,
protocols, tools, and strategies

Participating in group activities, including program-wide Work
Group and Steering Committee meetings

Providing integrative, organizational, and logistical support for
the entire program, including tracking, scheduling, and facilitating work group
meetings, committee meetings, and conference calls, preparing concise minutes
or summaries of meetings for distribution

Cooperating with other awardees in the publication and
dissemination of program results and the eventual release to the scientific and
healthcare communities of methods, tools, results, and other resources

Providing high-quality documentation as needed, particularly of
protocols or approaches that have broad applicability across the program that
will be sufficient for outside users to understand and apply to their research
projects with minimal assistance

Sharing resources, data, and software according to the goals for
the NIH-DoD-VA Pain Management Collaboratory program and approved Plans

Planning and hosting the face to face meetings, video
conferencing, or teleconferences of the Work Groups, Steering Committee, and
any subcommittees

Agreeing to accept close coordination, cooperation, and
management of the project with NIH, DoD, and VA, including those outlined under
“NIH, DoD, and VA Responsibilities”

Submitting periodic progress reports, in a standard format, as
agreed upon by the Steering Committee, and the NIH, DoD, and VA.

Awardees will retain custody of and have primary rights to the
data and software developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

The
NIH, DoD, and VA staff have substantial programmatic involvement that is above
and beyond the normal stewardship role in awards, as described below:

The Coordinating Center will have an NIH Project Coordinator provide
substantial programmatic assistance related to the award. In addition, NIH
will assign a Project Scientist who will be substantially involved in the
scientific activities of the Coordinating Center. Note that each of the
accompanying pragmatic trials will also be assigned an NIH Program Official
(PO) and Project Scientist, or the equivalent from the DoD or VA if they are
the funder of the Pragmatic Trial.

The designated NIH Project Coordinator / Project Scientist for
the Coordinating Center and NIH, DoD, and VA PO and Project Scientists for the accompanying
Pragmatic Clinical Trials (UG3/UH3s) will work with the Principal Investigator
and the Steering Committee to ensure the objectives of the program are being
met. The dominant role and prime responsibility for the program resides
with the awardee, although specific tasks and activities will be shared among
the awardee and the NIH, Program Coordinator.

The NIH, DoD, and VA PO/ Project Coordinator and Project Scientists
will provide technical assistance, advice, and coordination; however, the role
of the NIH, DoD, and VA staff will be to facilitate and not to direct
activities. It is anticipated that decisions in all activities will be
reached by consensus of the program and NIH, DoD, and VA will be given the
opportunity to offer input to this process.

The NIH Project Coordinator and Project Scientists serve as the
contact points for addressing the program objectives with the awardee.

Additional NIH, DoD, and VA Project Coordinators, POs and Project
Scientists may participate in all work groups, implementation teams, and
committees, including the Steering Committee, as appropriate. Participation by POs
and Project scientists from other federal agencies may also be appropriate and
advantageous to facilitate the activities of the program.

The NIH in consultation with DoD and VA reserves the option to
recommend withholding or reduction of support from activities that fail to
achieve their goals or comply with the Terms and Conditions.

NIH, DoD, and VA Project Coordinators, POs and project scientists
may serve as resources for, or interface with, other ongoing NIH, DoD, and VA
activities that may be relevant to the activities in the NIH-DoD-VA Pain
Management Collaboratory to avoid duplication and facilitate collaboration and
communication in overlapping areas.

Assist in development, design, and coordination of activities and
projects.

Responsibility for monitoring progress, which could include
regular communications with grantee and coordinating center staff, periodic
site visits, observation and review of demonstration project implementation
plans and testing, annual face to face in progress reviews that will be held in
the greater Washington D.C. area, and requests for additional reports or
documentation.

Reporting periodically on progress of the program to the Director,
NCCIH; other interested NIH IC Directors; the National Advisory Council for
Complementary and Integrative Health, the DoD, and VA.

An NIH program official will be responsible for the normal
programmatic stewardship of the award and will be named in the award notice.
Additionally, an agency project scientist will be responsible for the
scientific stewardship of the cooperative agreement award and will be named in
the award notice.

Areas
of Joint Responsibility include:

Awardee(s) agree to the governance through a Steering
Committee. An NIH-DoD-VA Pain Management Collaboratory program Steering
Committee will be established to address issues that span all projects, provide
input into the policies and processes of the NIH-DoD-VA Pain Management Collaboratory,
and assist in dissemination of policies and processes that enable research in
partnership with health care systems, their patients, and practitioners.
At a minimum, the Steering Committee will comprise one representative from each
of the Demonstration Projects; one representative from each Work Group; one
representative from the Coordinating Center; the NIH, DoD and VA Project
Coordinator, POs and Project Scientists for each of the awards in the program;
and representatives from various NIH ICs, the DoD, and VA. All members
are expected to actively participate in all Steering Committee
activities. The combined vote of NIH, DoD, and VA programmatic membership
may never exceed 40 percent.

NIH-DoD-VA Pain Management Collaboratory Work Groups will be established
as the core collaborative activity of this program. The Work Groups will
provide a forum for discussion of challenges and solutions across projects;
harmonized and standardized policies and processes will be vetted in these
groups. Work Groups are expected to be established in the following
areas, at a minimum: Stakeholder Engagement, Ethical/Regulatory, Study
Design/Biostatistics, Phenotype/Outcomes, Electronic Health Records, and Data
Sharing. Work Groups will be chaired by Coordinating Center staff and open to
participation by individuals from all funded Demonstration Projects, the
Coordinating Center, and the NIH, DoD, and VA.

Establishment and adherence by each Demonstration Project Team
(Demonstration Project grantee, Coordinating Center grantee, and NIH, DoD, and
VA staff) to a written plan of engagement with timelines to ensure delineation
of roles and timely delivery of the tested implementation plan.

Demonstration Project grantees will work with the Coordinating
Center and NIH, DoD, and VA, through all phases of their projects, including
the implementation and close out phase, to assure all resources, materials,
protocols, data, best practices, and lessons learned, as well as software or
sets of code, are disseminated broadly through the Coordinating Center with all
NIH-DoD-VA Pain Management Collaboratory program resources.

All awardees and NIH, DoD, and VA will cooperate to ensure the
timely and broad dissemination of all NIH-DoD-VA Pain Management Collaboratory
program endorsed policies and practices and lessons learned in the program to
inform researchers and health care systems engaged in research in health care
settings.

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
will be convened. It will have three members: a designee of the Steering
Committee chosen without NIH PO or Project Scientist voting, one NIH designee,
and a third designee with expertise in the relevant area who is chosen by the
other two; in the case of individual disagreement, the first member may be
chosen by the individual awardee. This special dispute resolution procedure
does not alter the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart
D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be made
publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.